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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PLGB 50697/0033.
Inaqovi 35 mg/100 mg film coated tablets
Inaqovi 35 mg/100 mg film-coated tablets
decitabine/cedazuridine
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Inaqovi is and what it is used for
2. What you need to know before you take Inaqovi
3. How to take Inaqovi
4. Possible side effects
5. How to store Inaqovi
6. Contents of the pack and other information
Inaqovi is a cancer medicine. It contains the active substances decitabine and cedazuridine.
Inaqovi is used alone to treat acute myeloid leukaemia (AML) in adults, when chemotherapy is not considered suitable. You will be given Inaqovi when you are first diagnosed with AML.
AML is a type of cancer affecting white blood cells called myeloid cells. In AML, myeloid cells multiply and grow very quickly in bone marrow and blood.
Inaqovi contains two active substances that work in different ways. Decitabine works by stopping cancer cells from growing. It also kills cancer cells. Cedazuridine does not affect the cancer cells directly, but it inhibits the break down of decitabine. This increases the amount of decitabine that is available in the body, and so helps to increase the effects of decitabine.
Talk to your doctor, pharmacist or nurse before taking Inaqovi if you:
Myelosuppression and ‘differentiation syndrome’
Inaqovi can cause serious myelosuppression (a condition in which the bone marrow cannot make enough blood cells), or a serious immune reaction called ‘differentiation syndrome’. Both may be fatal.
Seek urgent medical attention if you notice any signs and symptoms (for symptoms see section 4)
Cardiovascular disease
Talk to your doctor if you have a history of heart problems so that you can be monitored for signs and symptoms of heart failure.
Blood tests
You will have blood tests while on treatment. These will occur before you start treatment with Inaqovi, at the start of each treatment cycle or if you notice any signs and symptoms of myelosuppression. These tests are to check that:
Your doctor may change or delay your dose of Inaqovi. Your doctor may also give you medicines to help prevent infections.
Children and adolescents under 18 years of age must not be given Inaqovi. This medicine has not been studied in this age group.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines before you begin treatment with Inaqovi. Inaqovi may affect the way some medicines work, especially if you are also taking the following medicines to treat:
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
You should not take Inaqovi during pregnancy as it may harm your unborn baby. If you are able to become pregnant, a pregnancy test is recommended before starting treatment with Inaqovi.
Contraception
Women who are able to become pregnant must use effective contraception both during treatment with Inaqovi, and for 6 months after taking the last dose of Inaqovi.
Men with female partners who are able to become pregnant must use effective contraception both during treatment with Inaqovi, and for 3 months after the last dose.
Talk to your doctor about the most effective methods of contraception.
Breast-feeding
Do not breast-feed during treatment with Inaqovi. This is because it is not known if Inaqovi passes into breast milk and whether this could harm your baby.
Male and female fertility
Inaqovi may affect fertility. It is not known if the effect on fertility is permanent. Talk with your doctor before taking this medicine if you have any concerns, or if you wish to conserve your sperm or freeze your eggs before starting treatment.
Inaqovi may affect your ability to drive or use tools or machines. If you feel tired or dizzy after taking Inaqovi, do not drive or use tools or machinery until you feel better.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
You will be prescribed this medicine by a doctor experienced in the use of anti-cancer medicines. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose is 1 tablet once a day for the first 5 days of a treatment cycle. This is followed by 23 days without taking this medicine. One treatment cycle has 28 days.
You will usually take Inaqovi for at least 4 cycles. Your doctor will do regular blood tests to check on how well you respond to the treatment. Your doctor may delay your dose and change the total number of cycles, depending on how you respond to the treatment.
If you vomit
If you vomit after taking a dose, do not take an additional dose that day. Take the next dose at the usual time the following day.
Your doctor may prescribe you additional medicine to take before each Inaqovi dose to avoid you feeling sick or having to vomit during the treatment.
Overdose can result in myelosuppression, sepsis or pneumonia (see section 4, Possible side effects). If you take more Inaqovi than you should, seek urgent medical attention.
If you miss a dose within 12 hours of the time you usually need to take it, you should take the missed dose as soon as possible and resume the normal daily dosing schedule.
If you miss a dose by 12 or more hours: Do no take a dose and take the next dose the following day at the usual time. Extend the dosing period by one day for every missed dose. Please ensure that you complete a total of 5 daily doses for each cycle.
If you stop taking this medicine your cancer may no longer be controlled, and your symptoms from the cancer may reoccur. Therefore, you should only stop taking this medicine if your doctor tells you to.
If you have any further questions on how to take this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor, pharmacist, or nurse immediately if you notice any of the following serious side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister strip after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Inaqovi are red, oval biconvex shaped film-coated tablets, 14 mm diameter, plain on one side and debossed with ‘H35’ on the other side.
They are supplied in foil blister packs containing 5 tablets.
For any information about this medicine, please contact:
This leaflet was last revised in 07/2023.